Facing nearly 2 million new tuberculosis cases every year ”more and more of them drug-resistant ” India has a bigger stake in finding abetter treatment for TB than any other country.
Yet until recently, obstacles hindered Indian scientists'efforts to conduct advanced research.
The reason? India's university professors are bogged downwith teaching, and few have the laboratory facilities needed to do cutting edgework. And every year, more of the best minds are lured away by thepharmaceutical industry ” which has little interest in TB, from which there islittle money to be made.
But a pioneering effort to discover new drugs using the“open source” model prevalent in the software industry could change that.
India's Open Source Drug Discovery network (OSDD), begun bythe government's Council for Scientific and Industrial Reseach in 2008, ismaking waves four years later. By leveraging more manpower, pooling laboratoryresources and tapping resources from a government committed to boosting Indianresearch, they are hoping to produce a groundbreaking TB drug.
“When the economies of the developing countries are doingwell, is it not time to address some of these neglected diseases?” said OSDDdirector T. Balganesh, former CEO of pharmaceutical company AstraZeneca India.
“It's very clear: If you don't do anything, don't expect thePfizers and AstraZenecas of the world to solve the problem.”
The OSDD hasn't had to spend much money so far. In its firstfour years, the open source network has drawn only around $3 million of about$10 million in funding allotted by the Indian government, as early projectsinvolved mainly time from researchers. But spending is ramping up.
“The more expensive activities are just picking up now,”Balganesh said. “For the next five years, we are in the ballpark of about700-800 crores [US$130-$145 million], and I believe a big chunk of that will beinvolved in the clinical trials that we are organizing.”
On March 24, 2012, World TB Day, OSDD announced it willconduct Phase II-b clinical trials for a new TB drug in India in conjunctionwith the Global Alliance on TB ” signalling that the race is on.
“We desperately need new TB drugs and therefore anyinitiative in this area is welcome,” said Dr. Madhukar Pai, a professor atMcGill University's Department of Epidemiology & Biostatistics who hasworked extensively on India's TB problem.
“In particular, it is great to see the Indian governmentinvesting in this effort. After all, TB continues to be a huge public healthproblem in India, and the emergence of severe forms of drug resistanceincreases the urgency for new TB drug development.”
So far, the OSDD network has roped in around 6,000scientists, 80 percent of them Indian, from some 130 countries. Along with theGlobal Alliance on TB, it's formed partnerships with around 40 Indianuniversities and multinationals like AstraZeneca, Hewlett-Packard, Infosys andSun Microsystems. And in addition to the TB treatment it's testing with theGlobal Alliance, the network also has two more anti-TB molecules in advancedstages of research, and has nascent programs in the works for malaria andLeishmaniasis ” a potentially fatal disease transmitted by certain species ofsand fly.
While Balganesh cautions that drug discovery is a long haul,some spinoff benefits of the program are starting to materialize. Todistinguish OSDD from the plethora of granting agencies that offer scientistsfunding, the network aims to offer its researchers capabilities that aren'treadily available in the Indian university system.
“We're not just giving money away,” said Balganesh. “Ifyou're working on an anti-microbacterial project, all these capabilities willnow become available to you free of cost. This will then entice people in theuniversities, who don't have these capabilities, to get involved. Even smallcolleges, people who have good ideas.”
For example, OSDD is tapping chemists at laboratories acrossthe country to develop a library of compounds with novel structures that willbe freely available for researchers working on any disease ” a plan that hasalready attracted interest from Balganesh's former colleagues in big pharma. Ithas also set up a central laboratory for anti-microbacterial testing ” which isnot available at university labs because it requires special containmentfacilities.
In another effort, Balganesh is working on hiring a contractresearch organization that will allow biologists to outsource their chemistrywork. And OSDD has already done complete gene sequences for 100 strains ofclinical and drug-resistant TB, and has contracted a small college to clonespecific genes on demand from network researchers. That means that its studentsmaster cloning and sequencing, and OSDD researchers can get clones overnight.
The idea is to leverage the strengths of the open sourcemodel “ the human resources available in the academic world ” to overcome thepublic system's chronic shortage of funds.
“The ability to take risks with projects is limited in thepharma world. Time's a constraint, money is a constraint, resources are aconstraint,” said Balganesh. “[Here] the risks are not lower, but because ofthe creative challenge you can take high-risk projects. The scientists arewilling to invest their time because it's appealing, and if you crack it, it'sa publication.”
In other words, where companies like Pfizer and AstraZenecahave billions of dollars to spend, they're very jealous of that money, becauseso few drugs ever make it to market, and they devote precious little todiseases that won't pay even if they can be cured. The biggest advantage thatOSDD has is scientists that are, essentially, willing to work for free.
“What I have seen is that the real bottom line is theemotional involvement,” said Balganesh. “This is a difficult disease. There aremany scientific challenges. And solving it can really benefit the patient. Thattranslates to emotional involvement, and that translates into people investingtime.”
